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What is Good Clinical Practice?

Liz Jergle Almquist

FoU-centrum Skåne

2014.06.16

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FoU-centrum Skåne

(R&D centre Skåne)

Support, information and education to scientists to improve the quality of clinical trials.

Preparation of applications to the authorities

Quality control of clinical trials

GCP education

Project management

Statistical support

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FoU-centrum Skåne

(R&D centre Skåne)

Staben för forskning och utbildning

Clinical study support: 4 clinical study managers

Medical statistics and epidemiology:

7 statisticians

Phase one unit: 10 study nurses and physician

BIG 3

READi

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The very first clinical trial

In 1747, James Lind, a British naval surgeon on the ship

Salisbury, performed a study of treatments for scurvy

(deficiency of vitamin C).

Twelve crew members were selected to receive one of six

treatments: cider, elixir of vitriol, vinegar, sea water, a

mixture of mustard, garlic and horseradish, and the last

group was given citrus fruits.

After 10 days the two men in the citrus group were almost

recovered. One returned to duty , the other one helped

nursing the others…

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Why clinical trials?

• Effective tool to investigate therapy, diagnosis

och prophylaxis

• Randomised – double blind – controlled (highest

level of evidence)

• The goal is to identify new standards of therapy

in a well-defined, limited population to benefit

the larger population

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Why Good Clinical Practice?

• International standard accepted worldwide

• A way to ensure that data generated by a clinical

trial are accurate, verifiable and reproducible

• Compliance with GCP provides public assurance

that the rights, safety, well-being, and

confideniality of trial participants are protected.

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Background to guidelines and

regulations

• The Jewish Chronic Disease Hospital Case

1963

• The Tuskegee Syphilis study 1932-1972. The

Belmont report

• Vipeholm study 1945-1951. ”Lördagsgodis”

• Thalidomide, late 1950s, teratogenicity

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Ethical background

Nürnberg code, 1947

Helsinki declaration WMA 1964, 1975, 1983, 1989,

1996, 2000, 2002, 2007, 2008, Fortaleza 2013

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ICH Guideline for

Good Clinical Practice

ICH-GCP is an international ethical and scientific

standard for designing, conducting, recording and

reporting clinical trials

CPMP/ICH/135/95, 17 January 1997

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GCP

Läkemedelslag

Läkemedelsförordningen

Patientdatalag

Offentlighets-och Sekretesslag

Patientskadelag

Datalag

Arkivlag

Arkivförordning

Personuppgiftslag

Personuppgiftsförordning

LV föreskrifter och allmänna råd om klinisk läkemedelsprövning

LVFS 1996:17

LV föreskrifter och allmänna råd om klinisk prövning av läkemedel för humant bruk

LVFS 2011:19

ICH guidelines for GCP

Declaration of Helsinki

Directive 2001/20/EC, 2005/28/EGImplementation of GCP

Detailed guidance-Adverse reactions reports-Eudravigilance database-EUDRACT database-Application Ethics Committe-Application authorities

Biobankslag

Etikprövningslag

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Helsinki declaration

”It is the duty of the physician to promote and

safeguard the health, well-being and rights of the

patients, including those who are involved in

medical research.”

”While the primary purpose of medical research is

to generate new knowledge, this goal can never

take precedence over the rights and interests of

individual research subjects.”

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Competence

• Competent and appropriately qualified

physician/other health care professional

• Ethics and scientific education and training

• Assessment of risks, burdens and benefits

• Adequate resources

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Safeguard the patients’ integrity,

rights and safety

• Adequate information about aim, method, risks,

discomfort and benefits

• Right to refuse participation, right to withdraw

consent at any time

• Freely given written informed consent

• Protect the confidentiality of personal information

• The risks must be monitored, managed and

documented.

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Scientific requirements

• Thorough knowledge of the scientific literature,

other relevant sources of information, and

adequate laboratory and, as appropriate, animal

experimentation

• Design and performance clearly described in a

research protocol

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Ethics committee approval,

registration and publication

• Approval of research protocol by an independent

research ethics committee before study start

• Every research study must be registered in a

publicly accessible database before recruitment

of the first subject

• The study results, positive as well as negative,

must be published or otherwise made publicly

avaliable.

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Introduction to ICH GCP

This guideline should be followed when generating

clinical trial data that are intended to be submitted

to regulatory authorities.

May also be applied to other clinical investigations

that may have an impact on the safety and well-

being of human subjects.

ICH GCP are based on the principles of the

Helsinki declaration.

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Clear, detailed study protocol –

a ”manual”

• Risk/benefit evaluation

• The rights, safety, and well-being of the trial

subjects are the most important considerations

• Adequate non-clinical and clinical information on

the study product to support the proposed

clinical study

• Statistical considerations, sample size

• Study protocol approved by the authorities

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Qualified physician and staff

• Physician and other staff should be qualified by

education, training and experience

• GCP training - mandatory

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The patient’s right, safety and

confidentiality should be protected

• Freely given informed consent prior to trial

participation.

• Documentation in medical records.

• Confidentiality of personal data records.

Identification replaced by a code in study

documents and database.

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During the study

• Effect and safety must be followed and

documented according to the protocol

• Serious side effects related to the study drug

must be reported to the European database

• Essential documents should be kept updated

• Quality control (monitoring) and quality

assurance

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Essential documents

Permit evaluation of the conduct of the study and

the quality of data – during the study and after.

Can assist in the successful management

Protocol, patient information, applications and

approvals, delegation list, CV, case record forms,

patient identification list, various instructions…

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Quality control

Verify

Rights and wellbeing of the patients are

protected

Trial data are correct and complete

The conduct of the study is in compliance

with the approved protocol, GCP and

regulatory requirements.

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Summary

Following GCP guidelines is a way to ensure that

data generated by a clinical trial are accurate,

verifiable, and reproducible.

Provides public assurance that the rights, safety,

well-being, and confidentiality of trial participants

are protected.